Surgical guides from scanned implant data

ABSTRACT

A method of making a patient specific surgical guide includes obtaining a virtual model of a fixation member, and virtually designing a guide that defines at least one hole that corresponds to a hole of the virtual model of the fixation member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/792,746, filed Mar. 11, 2013, which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/645,890 filed May 11, 2012,U.S. Provisional Patent Application Ser. No. 61/642,063 filed May 3,2012, and also U.S. Provisional Patent Application Ser. No. 61/699,938filed Sep. 12, 2012, the entire disclosures of which are herebyincorporated by reference into this patent application for all purposes.

TECHNICAL FIELD

The present disclosure generally relates to apparatus and methods formanufacturing a surgical guide, and more particularly, to apparatus andmethods for manufacturing a patient specific resection guide.

BACKGROUND

Many surgical procedures require accurate cuts of bone. For example, inmandibular reconstruction surgery, deficient or infectious portions ofthe mandible may be removed from the patient and replaced with bonegraft. In some instances, a surgeon performing mandibular reconstructionsurgery typically makes several cuts on the mandible to properly fit abone graft. To make an accurate cut, the surgeon may use a resectionguide to guide the motion of the resection tool toward the bone. Theresection guide can also be used to cut a bone portion from otheranatomic locations of the patient in order to harvest bone grafts.

As discussed above, resection guides are typically used to make accuratecuts on the patient's anatomy. Although many resection guides have beendeveloped over the years, it is still desirable to produce resectionguides that are specifically designed for a particular patient in orderto enhance cutting accuracy.

SUMMARY

The present disclosure relates to methods of making a patient specificsurgical guide that is configured to guide a movement of a tool toward atissue body. In an embodiment, the method includes the following steps:(1) obtaining a virtual three-dimensional model of a fixation member,the obtained virtual three-dimensional model of the fixation memberhaving a planned post-operative shape and defining at least one holethat is configured to receive a fastener; (2) processing the virtualthree-dimensional model of the fixation member so as to couple thevirtual three-dimensional model of the fixation member to a firstvirtual three-dimensional model of the tissue body, the first virtualthree-dimensional model of the tissue body defining a first region, suchthat a central axis of the at least one hole is substantially alignedwith a first target location of the first region; (3) creating a virtualthree-dimensional model of a guide that defines at least one hole; and(4) processing the virtual three-dimensional model of the guide so as tocouple the virtual three-dimensional model of the guide to a secondvirtual three-dimensional model of the tissue body having a secondregion that is substantially identical to the first region, such that acentral axis of the at least one hole is substantially aligned with asecond target location of the second virtual three-dimensional model ofthe tissue body, wherein the second target location is positionedidentically with respect to the first target location relative to therespective first and second virtual three-dimensional models of thetissue body.

In an embodiment, the method includes the following steps: (1)processing a virtual three-dimensional model of a fixation member so asto couple the virtual three-dimensional model of the fixation member toa first virtual three-dimensional model of the tissue body, the firstvirtual three-dimensional model of the tissue body defining a firstregion, such that a central axis of the at least one hole issubstantially aligned with a first target location of the first region;(2) creating a virtual three-dimensional model of a guide that definesat least one hole; and (3) processing the virtual three-dimensionalmodel of the guide so as to couple the virtual three-dimensional modelof the guide to a second virtual three-dimensional model of the tissuebody having a second region that is substantially identical to the firstregion, such that a central axis of the at least one hole issubstantially aligned with a second target location of the secondvirtual three-dimensional model of the tissue body, wherein the secondtarget location is positioned identically with respect to the firsttarget location relative to the respective first and second virtualthree-dimensional models of the tissue body.

In an embodiment, the method includes the following steps: (1) obtaininga virtual three-dimensional model of the tissue body; (2) identifying onthe virtual three-dimensional model of the tissue body a first regionand a second region; (3) obtaining a virtual three-dimensional model ofa fixation member, the obtained virtual three-dimensional model of thefixation member having a planned post-operative shape and defining atleast one first hole that is configured to receive a fastener; (4)processing the virtual three-dimensional model of the fixation member soas to couple the virtual three-dimensional model of the fixation memberto the virtual three-dimensional model of the tissue body, such that acentral axis of the at least one first hole is substantially alignedwith a first target location of the second region; (5) creating avirtual three-dimensional model of a resection guide that defines atleast a pair of cutting guides and at least one second hole; and (6)processing the virtual three-dimensional model of the resection guide soas to couple the virtual three-dimensional model of the resection guideto a virtual three-dimensional model of a graft portion disposed betweenthe cutting guides, the graft portion sized to fit in the second region,such that a central axis of the at least one second hole issubstantially aligned with a second target location of thethree-dimensional model of the graft portion, wherein the second targetlocation substantially coincides with respect to the first targetlocation when the graft portion is positioned in the second region.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the application, will be better understoodwhen read in conjunction with the appended drawings. For the purposes ofillustrating the surgical instruments and methods of the presentapplication, there is shown in the drawings preferred embodiments. Itshould be understood, however, that the application is not limited tothe specific embodiments and methods disclosed, and reference is made tothe claims for that purpose. In the drawings:

FIG. 1A is a front elevation view of a resection guide coupled to apatient's tissue body;

FIG. 1B is a side elevation view of the resection guide shown in FIG.1A;

FIG. 1C is a front elevation view of the tissue body shown in FIG. 1Aafter a tissue portion has been removed from the patient;

FIG. 1D is a side elevation view of a virtual three-dimensional model ofa graft source;

FIG. 1E is a side elevation view of another resection guide coupled tothe graft source;

FIG. 1F is a perspective view of a fixation member coupled to thepatient's tissue body shown in FIG. 1A;

FIG. 2 is a diagram illustrating the method of making any of theresection guides shown in FIGS. 1A, 1B, and 1E, in accordance with anembodiment of the present disclosure;

FIG. 3A illustrates a physical model of a tissue body in a pre-operativecondition and a fixation member applied to the physical model, accordingto an embodiment of the disclosure;

FIG. 3B illustrates a virtual three dimensional model of the physicalmodel and fixation member shown FIG. 3B;

FIG. 3C illustrates a virtual three-dimensional model of a resectionguide fixation member applied to the tissue body in an intra- orpost-operative configuration;

FIG. 3D illustrates a virtual three dimensional model of a resectionguide and a tissue body, in accordance with an embodiment of thedisclosure;

FIG. 4A is a front elevation view of the fixation member shown in FIG.1F;

FIG. 4B is a top view of the a fixation member rand a marker shown inFIG. 4A, according to an embodiment of the disclosure;

FIGS. 5A and 5B illustrate a virtual three-dimensional model of thefixation member applied to the tissue body, and a virtualthree-dimensional model of a resection guide applied to the graftsource, respectively, illustrating how the virtual three-dimensionalmodel of the resection guide includes elements that correspond to thevirtual three-dimensional model of the fixation member;

FIG. 6 is a flowchart that describes a method of making a resectionguide in accordance with an embodiment of the present disclosure;

FIG. 7 is a flowchart that describes a method of making a resectionguide in accordance with another embodiment of the present disclosure;and

FIG. 8 is a flowchart that describes a method of making a resectionguide in accordance with another embodiment of the present disclosure.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower” and “upper”designate directions in the drawings to which reference is made. Thewords “proximally” and “distally” refer to directions toward and awayfrom, respectively, the surgeon using the surgical device. The words,“anterior”, “posterior”, “superior”, “inferior” and related words and/orphrases designate preferred positions and orientations in the human bodyto which reference is made and are not meant to be limiting. Theterminology includes the above-listed words, derivatives thereof, andwords of similar import.

With reference to FIGS. 1A-1C, a surgical system 8 can include one ormore resection guides 100 and 200 that can be coupled to a tissue body10 to guide one or more tools 101 toward the tissue body 10 in order toprepare the tissue body 10 for receiving a graft. For instance theresection guides 100 and 200 can guide a tool 101 that cuts the tissuebody 10 so as to create a void 14 (FIG. 1C) in the tissue body 10. Thetissue body 10 can define spaced apart first and second tissue portions12 a and 12 b. The first and second tissue portions 12 a and 12 b can beany particular portions or segments of the tissue body and are usedherein to refer to tissue portions that define the void 14. Further, theresection guides 100 and 200 can be used to guide a drill bit that formanchoring locations 22 (FIG. 1B), for instance bores or holes, in thetissue body 10. Anchoring locations are used to allow an anchor or screwto couple a bone fixation member, such as plate, to the tissue body 10as detailed below. It should be appreciated that the cutting tool 101may be a saw, blade, a drill bit, or any other tool capable of cuttingor otherwise preparing tissue. As used herein, the tissue body 10 caninclude a patient's bone, such as the mandible 12, and can include thefirst and second tissue portions 12 a and 12 b. The tissue body 10 canalso include anatomical tissue, synthetic tissue, or both. Although thedrawings illustrate a mandible 12, the tissue body 10 can be other partsof the patient's anatomy such as a maxilla.

Referring to FIG. 1A, the resection guide 100 is configured to becoupled to the tissue body 10 and can include a resection guide body 102that is configured to abut at least a portion of the tissue body 10, forinstance tissue portion 12 a. The resection guide body 102 can define aninner surface (not shown) that is contoured to match the contour of aparticular outer surface of the tissue body 10 so that the resectionguide 100 can only fit over the that particular outer surface of thetissue body 10. The resection guide 100 can define one or more slots 104that are configured and sized to receive the cutting tool 101 therein.The slot 104 can extend through the resection guide body 102, and can beelongate along a first resection axis 108. The tissue body 10 can be cutby inserting the cutting tool 101 through the slot 104 when theresection guide 100 is coupled to the tissue body 10. In particular, theslot 104 guides the movement of the cutting tool 101 toward the tissuebody 10 along the first resection axis 108.

In addition to the slot 104, the resection guide 100 can further includeone or more drill holes 106 that extend through the resection guide body102. Each of the drill holes 106 is configured and sized to receive adrill bit or any other suitable tool capable of making holes into and/orthrough the tissue body 10. The drill holes 106 can be elongate along ananchoring location axis 20. The anchoring location axis 20 thus extendsthrough the drill hole 106 into alignment with then anchoring location22, for instance a hole or bore, formed in the tissue body by the drillbit inserted through the drill hole 106. The anchoring location 22 isconfigured and sized to receive an anchor or fastener.

The resection guide 100 can further define one or more fastener holes107 that are configured and sized to receive a fastener, such as a pin,a wire, or a screw therethrough. Each of the fastener holes 107 extendsthrough the resection guide body 102 and is configured to guide themovement of the fastener through the resection guide body 102 in orderto temporarily couple the resection guide 100 to the tissue body 10.

When resection guide 100 is coupled to the tissue body 10, the cuttingtool 101 can be inserted through the slot 104 and into the tissue body10 to make a cut on the tissue body 10 at the desired anatomicallocation. Further, the drill bit can be inserted through the drill holes106 to form the anchoring locations in the tissue body 10. The fastenersinserted through the fastener holes 107 can then be withdrawn from thetissue body 10 and the resection guide body 102 to decouple theresection guide 100 from the tissue body 10. Although the presentdisclosure mostly refers to resection guides, any of the resectionguides described herein may alternatively be positioning guides, drillguides, or any other guide defining at least one hole that is configuredto receive a cutting tool such as a drill bit.

With reference to FIG. 1B, the resection guide 200 is configured to becoupled to the tissue body 10 to guide the movement of one or more tools101 toward the tissue body 10 in order to prepare the tissue body 10.The resection guide 200 is configured similarly to the resection guide100, however, the resection guide 200 can be coupled to the tissue body10 at a location spaced from the resection guide 100. The resectionguides 100 and 200 can be used to guide a tool 101 to resect tissue fromthe tissue body 10 so as to create the void 14 (FIG. 1C). The resectionguide 200 can include a resection guide body 202 that is configured toabut at least a portion of the tissue body 10, for instance tissueportion 12 b. The resection guide body 202 can define an inner surfacethat is contoured to match the contoured of a particular outer surfaceof the tissue body 10 so that the resection guide 200 can only fit overthe that particular outer surface of the tissue body 10. The resectionguide 200 can define one or more slots 204 that are configured toreceive the cutting tool 101. In the depicted embodiment, the resectionguide 200 can define a first slot 204 and a second slot 205. Each of thefirst slot 204 and the second slot 205 extends through the resectionguide body 202, and each can be configured to receive the cutting tool101. The first slot 204 can be elongate along a first resection axis 208such that the first slot 204 can guide the movement of the cutting tool101 into the tissue body 10 along the first resection axis 208. Thesecond slot 205 can be elongate along a second resection axis 209 suchthat the second slot 205 can guide the movement of the cutting tool 101into the tissue body 10. The first resection axis 208 can be oriented atan oblique angle relative to the second resection axis 209. Inoperation, the cutting tool 101 can be inserted through slot 204 and 205and into the tissue body 10 to cut the tissue body 10.

In addition to the first slot 204 and the second slot 205, the resectionguide 200 can define one or more drill holes 206 that extend through theresection guide body 202. Each of the drill holes 206 is configured andsized to receive a drill bit or any other suitable tool capable ofmaking holes into and/or through the tissue body 10. The drill holes 206can be elongate along an anchoring location axis 24. The anchoringlocation axis 24 thus extends through the drill hole 106 into alignmentwith anchoring location 22, for instance a hole or bore, formed in thetissue body by the drill bit inserted through the drill hole 206. Theanchoring location 22 is configured and sized to receive an anchor orfastener.

The resection guide 200 can further define one or more fastener holes207 that extend through the resection guide body 202 that are configuredand sized to receive a fastener, such as a pin, a wire, or a screw, thatis used to temporarily couple the resection guide 200 to the tissue body10. Once the resection guide 200 is coupled to the tissue body 10, thecutting tool 101 can be inserted through the slot 204 and into thetissue body 10 to make a cut on the tissue body 10 at the desiredanatomical location. Further, the cutting tool 101 can be insertedthrough the slot 205 and into the tissue body 10 to make a cut on thetissue body 10 at the desired anatomical location. A drill bit caninserted through the drill guide holes 206 to form an anchoring location22 in the tissue body 10. When cuts have been made on the tissue body 10along the resection axes 108, 208, and 209, a portion of the tissue body10 can be removed from the patient. The fasteners inserted through thefastener holes 207 can be withdrawn from the tissue body 10 to decouplethe resection guide 200 from the tissue body 10.

With reference to FIG. 1C, as discussed above, cuts can be made on thetissue body 10 along the resection axes 108, 208, and 209 to allowremoval of a tissue portion from the tissue body 10, thereby defining avoid 14 in the tissue body 10. The void 14 extends between the cut,exposed surfaces of the tissue portion 12 a and 12 b. The removed tissueportion can be damaged or diseased tissue. The void 14 of the tissuebody 10 can be filled with the graft, and the graft coupled to thetissue portions 12 a and 12 b with the bone fixation element, or plate,as discussed in detail below.

With reference to FIGS. 1D-E, as discussed above, the removed tissueportion can be replaced with the graft, such as graft 320 (FIG. 1F). Thegraft can be harvested from any suitable graft source 300, such as avascularized bone graft source. Further, the graft can be an autologousgraft. Examples of suitable graft sources include, but are not limitedto, the scapula, hip, rib, forearm, among others. The graft source 300can also be a fibula 302. Regardless of the kind of graft sourceselected, the graft source 300 can be cut at appropriate locations andorientation to obtain a graft that properly fits in the void 14 (FIG.1C) defined by the cut exposed surfaces of the tissue portions 12 a and12 b. To define size and shape of the desired graft, a virtualthree-dimensional model 301 of the graft source 300 can be obtained todetermine the appropriate location and orientation of the cuts to bemade to harvest a graft from the graft source 300. The virtualthree-dimensional model 301 of the graft source 300 can be obtained byscanning the graft source 300 using any suitable technology such asx-ray computed tomography (CT), or any suitable mapping technology forinstance, laser, optical, CT, magnetic resonance imaging (MRI) andcoordinate measuring machines. In an embodiment, an imaging machine,such as CT scan machine, can be used to scan the graft source 300. Theimaging machine can include or be in electronic communication with acomputer, such a computer 530, that includes a computer memory inelectronic communication with a processor. The computer 530 can be anycomputing device and can include a smart phone, tablet or any othercomputer. The data obtained by scanning the graft source 300 cantransmitted to or stored in the computer memory. The scanned data can beprocessed, via the processor, and in accordance with softwareinstructions running on the computer 530, to create the virtualthree-dimensional model 301 of the graft source 300. Alternatively, thescanned data can be downloaded or transferred wirelessly or via ahardwire connection over an electronic communications network to adifferent computing device at a location that is remote from the imagingmachine, in order to create the virtual three-dimensional model 301 ofthe graft source 300.

When the virtual three-dimensional model 301 of the graft source 300 hasbeen obtained, the surgical operation can be planned. The surgicaloperation can be planned using any suitable software program that isconfigured to process, edit and manipulate data that is representativeof the image of the scanned graft source, for instance scanned imagedata. The software operate over networked computing architecture thatincludes host and client computing devices. Further, the software can bea web based application configured to process instructions based oninputs from a graphical user interface running on a computer, forinstance computer 530. In an embodiment, one suitable software programconfigured to process, manipulate and or edit images or image data, issold or licensed under the trademark PROPLAN CMF® by Synthes. PROPLANCMF® can be used to process and manipulate the virtual three-dimensionalmodel 301.

The graft 320 that replaces the removed tissue portion should beconfigured and sized to fit properly in the void 14 (FIG. 1C). Forinstance, a plurality of graft portions 304, 306, and 308 can beharvested from the graft source 300 and then interconnected to from acomplete graft for insertion in the void 14. As such, resection axes canbe defined as so the form the plurality of graft portions 305, 306, and308. Using the virtual three-dimensional model 301 of the graft source300, the resection can be planned via the computer running software thatis configured to process, manipulate and edit images, such as thescanned image data described above. The user can input instructions thatcauses the processor to carry out the desired edits or manipulations tothe virtual three-dimensional model 301 of the graft source 300. Theuser can determine the location and the orientation of the resections tobe made on the graft source 300 to obtain graft portions 304, 306, and308 that can later be interconnected to form the graft 320. To harvestthe graft portions 304, 306, and 308, the user can determine that cutshave to be made along the resection axes 310, 312, 314, 316, and 318. Itshould be appreciated that patient anatomy and shape and size of theremoved tissue portion, resections can be made along other resectionaxes to form the properly sized graft portions.

With continuing reference to FIGS. 1D-E, after planning the desiredresections to be made on the graft source 300 using the virtualthree-dimensional model 301 in the computer, the resection guide 400configured in accordance with the planned surgical procedure andmanufacturing using rapid production technology as described below canbe placed on the graft source 300 to guide the movement of the cuttingtool 101 into the graft source 300. The resection guide 400 can includea resection guide body 402 that is configured and adapted to abut atleast a portion of the graft source 300. The resection guide body 402can define an inner surface that can be contoured to match a particularouter surface of the graft source 300 so that the resection guide 400can only fit over the that particular outer surface of the graft source300.

The resection guide 400 defines a plurality of slots that are eachconfigured to receive the cutting tool 101 to guide the movement of thecutting tool 101 toward the graft source 300. In the depictedembodiment, the resection guide 400 can define a first slot 410, asecond slot 412, a third slot 416, and a fourth slot 418 that are spacedfrom one another. Each of the slots 410, 412, 416, and 418 extendthrough the resection guide body 402. The resection guide 400 can beconfigured so that the slots 410, 412, 416, and 418 are substantiallyaligned with the predetermined resection axes 310, 312, 314, 316, and318 when the resection guide 400 is placed over the graft source 300.For example, the first slot 410 can be substantially aligned with thefirst resection axis 310 when the resection guide 400 is placed over thegraft source 300. The second slot 412 can be substantially aligned withthe second resection axis 312 when the resection guide 400 is placedover the graft source 300. The third slot 414 can be substantiallyaligned with the third resection axis 314 when the resection guide 400is placed over the graft source 300. The fourth slot 416 can besubstantially aligned with the fourth resection axis 316 when theresection guide 400 is placed over the graft source 300. The fifth slot418 can be substantially aligned with the fifth resection axis 318 whenthe resection guide 400 is placed over the graft source 300.

In addition to the slots, the resection guide 400 can further define oneor more drill holes 406 that are configured and sized to receive atleast one drill bit or any other apparatus that is capable of makinganchoring locations 303, such as a hole or bore, in the graft source300. In operation, the drill bit can be inserted through some or all ofthe drill holes 406 to make a hole in the graft source 300. Theanchoring locations formed in the graft source 300 are configured andsized to receive an anchor, such as screw, rivet, nail or an suitablebone fixation device. The anchoring locations 303 can correspond toopenings formed in a fixation member, such as plate, such that theanchor can be inserted through fixation member openings into therespective anchoring locations 303 in the graft source 300, as discussedbelow.

The resection guide 400 can further define one or more fastener holes407 that are configured and sized to receive a fastener, such as a pin,a wire, or a screw. The fastener can be inserted through the fastenerholes 407 and into the graft source 300 to temporarily couple theresection guide 400 to the graft source 300. The resection guide 400 canbe coupled to the graft source 300 by inserting fasteners through thefastener holes 407. Then, the cutting tool 101 can be insertedsequentially through the slots 410, 412, 416, and 418 and advanced intothe graft source 300 to so as to cut and harvest the graft portions 304,306, and 308. A drill bit can inserted in the drill holes 406 to formanchoring locations 303 (not shown) in the graft source portions 304,306, and 308 The resection guide 400 can then be decoupled from thegraft source 300 by removing the fastener from the fastener holes 407and the graft source 300.

With reference to FIG. 1F, the graft portions 304, 306, and 308 can thenbe placed in the void 14 (FIG. 1C) in order to replace the tissueportion removed from the tissue body 10. The graft portions 304, 306,and 308 can then be coupled to each other to form the graft 320. Anysuitable fixation member 322, such as a fixation plate 324, and aplurality of anchors, such as screws can be used to couple the graftportions 304, 306, and 308 can together to form the graft 320. The graft320 can be a bone graft, and can be connected to the tissue body 10using the fixation member 322, such as the fixation plate 324.

In an embodiment, the fixation member 322 can be configured as a bonefixation implant. The fixation member 322 can be bent so that itscontour matches the contour of the tissue body 10 and the interconnectedgraft portions 304, 306, and 308. For instance, the fixation member 322can be countered along the tissue portion 12 a, the graft 320 and tissueportion 12 b. Further, the fixation member 322 defines one or more holes326 that are configured to receive a anchors discussed above. The holes326 can be threaded holes or partially threaded depending on theselected anchor type. When the fixation member 322 is placed against thetissue body 10 and the graft portions 304, 306, and 308, one or moreanchors can be inserted through at least one fastener hole 326 and intoanchoring locations 22 in the tissue body 10 or the anchoring locations303 formed in the graft 320 so as to couple the graft portions 304, 306,and 308 to one another and to couple the graft 320 to the tissue body10. The fixation member 322 can be formed from a variety ofbiocompatible materials, such as cobalt chromium molybdenum (CoCrMo),titanium, and titanium alloys, stainless steel, ceramics, or polymerssuch as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), andbioresorbable materials. A coating may be added or applied to the bonefixation implant 410 to improve physical or chemical properties or toprovide medications. Examples of coatings include plasma-sprayedtitanium coating or Hydroxyapatite. In accordance with an alternativeembodiment, the fixation member 322 can be patient specific bonefixation plate.

Referring to FIGS. 2 and 3A-3D, 5A and 5B, a method of making a patientspecific surgical resection guide, for instance any of the resectionguides 100, 200 and/or 400 described above disclosure or any othersuitable resection guide. The method can include all or some of thesteps schematically represented as steps A, B, C, D, E, and F in FIG. 2,some of which are carried out using one or more computing devices, orcomputers 530 running suitable software used to manipulate or editimages and or three-dimensional models. In accordance with theembodiment illustrated in FIG. 2, the method of making a patientspecific surgical guide can include in step A obtaining a physical modelof a tissue body and a fixation member, for instance fixation member322. Step B can include scanning the physical model of the tissue bodyand the fixation member using a scanning and or mapping machine 508.Step C can include creating a virtual three-dimensional model of thephysical model and the fixation member on a computer 530. Step D caninclude creating a virtual three-dimensional model of the fixationmember applied to the tissue body in an intra- or post-operativeconfiguration. Intra- or post-operative configuration means the desiredor intended shape of the tissue body and fixation member when the tissuebody 10 has been surgically reconstructed with graft an fixation member.Step E can include creating a virtual three-dimensional model of aresection guide based on the intra- or post-operative virtualthree-dimensional model of the tissue body and the fixation member. StepF can include making a surgical resection guide based on the virtualthree-dimensional model of the resection guide.

Referring FIGS. 2 and 3B, in step A the user obtains a physical model500 of the tissue body 10. The tissue body 10 can be a native tissuebody or a reconstructed tissue body. The physical model 500 of thetissue body 10 can be created by scanning the tissue body 10 using anysuitable technology and then forming a three-dimensional model based onthe scanned data. For instance, a virtual three-dimensional model 510 ofthe tissue body 10 can be obtained by scanning the tissue body 10 usingany suitable technology, such as CT scan machine, laser scanningmachine, optical scanning machine, MRI machine, and coordinate measuremachine. In an embodiment, a scanning machine can be used to scan atissue body 10 so as to obtain scanned data of the tissue body 10. Thescanned data is then downloaded or transferred to a computer inelectrical communication with the scanning machine. For instance thescanned data can be transmitted wirelessly or via hard connectionthrough a LAN, WAN or any suitable communications network to thecomputer. In the computer, a virtual three-dimensional model 510 of thetissue body 10 is created using a computer running suitable softwarecapable of processing and editing, or manipulating images and/or imagedata. The virtual three-dimensional model 510 of the tissue body 10 is arepresentation of the tissue body 10 in its pre-operative condition. Asfurther detailed below, the virtual three-dimensional model 510 of thetissue body 10 can be manipulated in accordance with a surgical plan inorder to obtain a virtual three-dimensional model 520 (FIG. 3C) of thetissue body 10 in its intra- or post-operative configuration. In otherwords, the virtual three-dimensional model 510 can be manipulated suchthat the model represents the desired or intended shape andconfiguration of the tissue body 10 when the resected tissue has bereplaced by the graft 320. The virtual three-dimensional model 520 ofthe tissue body 10 is downloaded or transferred via a communicationsnetwork to a manufacturing machine or machines. Then, using the virtualthree-dimensional 520 model of the tissue body 10, the manufacturingmachine can create a physical model 500 (FIG. 3A of the tissue body 10in its intra- or post-operative condition. For instance, a rapidprototyping device or process can be used to create the physical model500 of the tissue body 10 using the virtual three dimensional model ofthe tissue body 10. In rapid prototyping manufacturing processes, avirtual design, such as a computer aided design model, is transformedinto a physical model. Examples of rapid prototyping devices andprocesses include, but are not limited to, selective laser sintering(SLS), fused deposition modeling (FDM), stereolithography (SLA), and 3Dprinting. A computer numerical control (CNC) machine can also be used tocreate the physical model 500 of the tissue body 10 in its pre-operativeor post-operative condition.

Once the user obtains the physical model 500 of the tissue body 10, thefixation member 322, such as a fixation plate 324 or any other bonefixation implant, can be coupled to the physical model 500. In thedepicted embodiment, the fixation plate 324 can bent to conform to theshape of the physical model 500. That is, the fixation member 322, suchas the fixation plate 324, can be shaped in accordance with a plannedpost-operative shape. The fixation plate 324 can be coupled to thephysical model 500 at the same location and in the same orientation onthe physical model 500 as it would be placed on the tissue body 10. Oneor more markers 502 can be at least partially inserted at least one ofthe holes 326 of the fixation member 322 to mark the location andangulation of that fastener hole 326. Each marker 502 can include ahandle 504 and a rod 506 that extends from the handle 504. At least aportion of the rod 506 can be configured and sized to be received by oneof the holes 326. The rod can define a length and in some embodiments,Some markers 502 can have rods 506 with shorter lengths than others. Themarkers 502 with the shorter length rods 506 can be positioned betweenmarkers 502 with longer rods 506 to accommodate the maximum number ofmarkers 502 in the fastener holes 326.

With reference to FIGS. 4A and 4B, the fixation member 322 can include afixation member body 321. The fixation member body 321 extends between afirst end 321 a and a second end 321 b opposite the first end 321 aalong a longitudinal direction L. The fixation body 321 defines an outersurface 323 and an inner surface 325 spaced from the outer surface 323along a transverse direction T that is transverse to the longitudinaldirection L. The inner surface 325 is configured so contour to thesurface of the graft source or tissue body 10. The fixation member 322has a thickness defined as the distance between the outer surface 323and the inner surface 325. The fixation member body 321 define aplurality of holes 326 that extend through the fixation member body 321along a central hole axis X. The holes 326 space apart from each otheralong longitudinal direction L. Each hole 326 is configured and sized toreceive at least an anchor therethrough. The holes 326 can be asthreaded or partially threaded. The holes 326 can be configured in anysuitable manner or orientation to receive an anchor therein. The centralhole axis X can thus be angulated respect to the direction T. In anembodiment, the central axes X of some or all of the holes 326 can beangularly offset relative to the direction T. The fixation member 322 isconfigured to be bent to conform to the shape of a portion of the tissuebody 10 or a portion of the physical model 500 of the tissue body asshown in step A of FIG. 3A. Before bending the fixation member 322,small screw inserts (not shown) can be placed in the holes 326 to helpmaintain the shape of the holes 326 during the bending process.Furthermore, the fixation member 322 is generally not bent or deformedat positions where the holes 326 are located to avoid, or at leastminimize significantly changing the shape of the holes 326 duringbending.

The markers 502 can be used to accurately create the holes 326 in avirtual three-dimensional model of the fixation member 322. As discussedabove in step A, markers 502 can be inserted through the holes 326 afterthe fixation member 322 has been bent to conform to the shape of atleast a portion of the physical model 500 and coupled to the physicalmodel 500. A portion of the marker 502, such as a portion of the rod506, can be inserted in one of the holes 326 such that that rod 506extends along the respective central hole axis X. Hence, the rod 506 canbe elongate along the central hole axis X of one of the holes 326 whenat least a portion of the rod 506 is inserted in that specific hole 326.Accordingly, markers 502 can be inserted in one or more holes 326 toidentify the angulation of the respective hole 326.

Referring to FIG. 2, in step B the physical model 500, the fixationmember 322, and the markers 502 can be scanned using any suitablescanning or imaging technology as described above to obtain scannedimage data for the physical model 500, the fixation member 322, and themarkers 502. For instance a scanning machine can be used to scan thephysical model 500, the fixation member 322, and the markers 502, andusing the scanned image data can be used, via a computer 530 to create avirtual three-dimensional model 512 of the physical model 500, thefixation member 322, and the markers 502. In accordance with analternative embodiment, only physical model 500 and the fixation member322 are scanned, and a virtual three-dimensional model is created of thephysical model 500 and the fixation member 322 such that the markers 502are not scanned. In a further embodiment, only the fixation member 322,which has been shaped in accordance with a planned intra- orpost-operative configuration, is scanned. In particular, the fixationmember 322 can be bent to a shape to its planned intra- orpost-operative shape and then scanned to obtained the scanned imagedata.

Referring to FIGS. 2 and 3B, in step C, once the three-dimensional imageof the fixation member 322 coupled to the physical model 500 is obtainedwith the scanning machine, the scanned image data is loaded onto acomputer 530 to create a virtual three-dimensional model 512 of thephysical model 500, the fixation member 322, and the markers 502.Alternatively, a virtual three-dimensional model of at least thefixation member 322 can be created with the computer 530 without theneed of scanned image data of the physical model 500 of the fixationmember 322. The computer 530 can include a processor and anon-transitory computer readable storage medium configured to storedata, such as scanned image data, and suitable software. The computer530 may be local, for instance in the same general area as the scanningmachine, or remote and the scanned image data is transferred to thecomputer 530 via a communications network. Thus the obtain or storedscanned image data can be manipulated by a user via software running onthe computer that is local to the scanning machine and/or surgerylocation or remote to the scanning machine and/or surgery location. Forexample, the scanned image data can be manipulated remotely by thesurgeon who will be performing the surgery. The virtualthree-dimensional model 512 is typically composed of data in differentformats. For instance, the three-dimensional model 512 can contain datain a Standard Tessellation Language (STL) format. Regardless of the dataformat, the virtual three-dimensional model 512 includes data that mapsand represents the shape, contour, and size of at least the physicalmodel 500 and the fixation member 322 as coupled to the physical model500.

Continuing with reference FIGS. 2 and 3B, in step C the virtualthree-dimensional model 512 can include data representing the markers502 position in the fixation members 322 so as to enhance the accuracyof the orientation of the holes 326 of the fixation member 322. With thevisual representation of the markers 502, the user can better determinethe orientation of the holes 326 of the fixation member 322. Asdiscussed above with respect to FIGS. 4A and 4B, the markers 502 canhelp determine the angulation of the hole 326 with respect to thetransverse on T of the fixation member 322. Using the scanning processin step B, the location of the opposed ends 327 of each hole 326 can beobtained. However, the path of each hole 326 from a first hole end 327to a second hole end 329 may not be necessarily obtained by the scanningprocess described in step B. Hence, the virtual three-dimensional model512 can be manipulated to virtually create each of the holes 326 virtualmodel of the fixation member 322. To do so, the central hole axis X canbe developed in the virtual model so to extend through the a center ofthe first hole end 327 and the center of the second hole end 329. Then,the hole 326 is created so that it has a path along the previously drawncentral axis X′ of that particular hole 326. This process does notentail the use of the markers 502. Alternatively, the visualrepresentation of the markers 502 can be used obtain a more accuratepath for the holes 326. To do so, the central axis X′ is drawn from thesecond hole end 329 to an end 507 of the rod 506 that is attached to thehandle 504. Then, the hole 326 that follows the central axis X iscreated in the virtual three-dimensional model 512. This process can berepeated for each hole 326.

In step C, the virtual three-dimensional model 512 can include models ofeach component. That is, the virtual three-dimensional model 512 caninclude a virtual three-dimensional model 514 of the physical model 500,a virtual three-dimensional model 516 of the fixation member 322, suchas the fixation plate 324, and a virtual three-dimensional model 518 ofthe markers 502. The virtual three-dimensional models 512 (or anyvirtual model described herein) can be manipulated by a user usingconventional software typical in the art. For example, a softwareprogram that is configured to process and edit images, sold under thetrademark PROPLAN CMF® by Synthes, may be used to process and manipulatethe virtual models obtain from the scanning machine 508. The softwareallows the user to analyze the tissue body 10 and pre-operatively planthe patient's surgery including the shape and design of a resectionguide, such as a resection guide 600 discussed below.

Referring to FIGS. 2 and 3C, in step D, the virtual three-dimensionalmodel 520 of the tissue body 10 can be manipulated into the intra- orpost-operative shape and configuration in accordance with a plannedsurgical procedure. Specifically, the virtual three-dimensional model516 of the fixation member 322 can be imported into a previouslyobtained three-dimensional model 520 of the tissue body 10, andmanipulated using a computer create a virtual three-dimensional model520 of the tissue body 10 in the intra- or post-operative shape andconfiguration. In other words, using the virtual three-dimensional model520 of the tissue body 10, the user may pre-plan a surgery, such as amandibular reconstruction surgery, in the computer 530 using a suitablesoftware such as the software sold under the trademark PROPLAN CMF® bySynthes. In the computer 530, the virtual three-dimensional model 516 ofthe fixation member 322 can be coupled to the virtual three-dimensionalmodel 520 of the tissue body 10 in the intra- or post-operativeconfiguration in accordance with a predetermined surgical plan asdiscussed in detail above with respect to FIG. 1F. Thus, the virtualthree-dimensional model 516 of the fixation member 322 can be alignedwith the virtual three-dimensional model 520 of the tissue body 10according to a desired surgical plan. As discussed above, thethree-dimensional model 520 can represent a native tissue body 10 or areconstructed tissue body 10 that includes the graft 320. The virtualthree-dimensional model 516 of the fixation member 322 coupled to thethree-dimensional model 520 of the tissue body 10 are collectivelyreferred to as the virtual three-dimensional model 526.

Referring to FIGS. 2 and 3D, in step E, a virtual three-dimensionalmodel 522 of a resection guide 600 can be created and designed based onthe virtual three-dimensional model 526 of the fixation member 322coupled to the tissue body 10. Thus, the resection guide 600 (or anyother suitable resection guide) can be designed and manufactured basedon the virtual three-dimensional model 526 of the fixation member 322coupled to the virtual model 520 of the tissue body 10. In accordancewith an alternate embodiment, the virtual three-dimensional model 522 ofthe resection guide 600 can be created using a virtual three-dimensionalmodel 521 of the tissue body 10 that has been previously obtained via ascanning machine. The virtual three-dimensional model 521 of the tissuebody 10 can be substantially identical to the virtual three-dimensionalmodel 520 of the tissue body 10 used in step D. However, in someembodiments, the virtual three-dimensional model 521 of the tissue body10 represents the tissue body 10 in a pre-operative shape or condition.

Continuing with reference to FIGS. 2 and 3D, in step E a virtualthree-dimensional model 522 of the resection guide 600 is can beconfigured to or designed to allow a surgeon to guide movement of thecutting tool 101 toward the tissue body 10, for instance when theresection guide is formed as detailed below. In the depicted embodiment,the resection guide 600, or the model of the resection guide, caninclude a resection guide body 602 that is configured to abut at least aportion of the tissue body 10. The resection guide body 602 can defineat least one slot 604 that extends through the resection guide body 602.The slot 604 can be configured and sized to receive the cutting tool101, and guide the cutting tool 101 toward the tissue body 10 when theresection guide 600 is coupled to the tissue body 10, as represented ina three-dimensional virtual model. In addition to the slot 604, theresection guide 600 can define one or more drill holes 606 that are eachconfigured and sized to receive a drill bit or any other apparatuscapable of making holes or anchoring locations in the tissue body 10.Each of the drill holes 606 can extend through the resection guide body602. In addition to the drill holes 606, the resection guide 600 candefine one or more fastener holes 607 that are each configured and sizedto receive a fastener such as a screw. Each of the fastener holes 607can extend through the resection guide body 602. At least one fastenercan be inserted through each fastener hole 607 and into the tissue body10 to couple the resection guide 600 to the tissue body 10.

Continuing with FIGS. 2 and 3D, in step E, the virtual three-dimensionalmodel 522 of the resection guide 600 can be designed such that thelocation and orientation of the drill holes 606 in the virtualthree-dimensional model 522 relative to the tissue body 10 aresubstantially aligned with the location and orientation of the samenumber of holes 326 of the fixation member 322. For instance, as show inFIG. 3C, in step C, the fixation member 322 includes first hole 326 anda second hole 326 b positioned at a location and orientation G and H,respectively, relative to the tissue body 10. Accordingly, the virtualthree-dimensional model 522 of the resection guide 600 can be designed,for example in the computer 530, such that at least one hole 606 a andsecond hole 606 b has substantially the same location and orientationrelative to the tissue body 10 as one of the holes 326, for instanceholes 326 a and 326 b, of the fixation member 322, relative to thelocation and orientations G and H on the tissue body 10. The location Gcan be referred to as the first position relative to the virtualthree-dimensional model 520, and the location identified H can bereferred to as the second position relative to the virtualthree-dimensional model 520. The holes 326 a and 326 b are located andoriented relative to the tissue body 10 such that the insertion ofanchors through the holes 326 a and 326 b into the anchor locations donot impinge upon nerves of the tissue body 10. Also, the holes 326 arelocated and oriented relative to the tissue body 10 such that anchorsare inserted through tissue that is not damaged or diseased.

Referring to FIG. 2, in step F, once the virtual three-dimensional model522 of the resection guide 600 has been completed, the resection guide600 can be made based on the three-dimensional virtual model 522 usingany suitable technology, such as the rapid prototyping technology. Forinstance, the virtual three-dimensional model 522 of the resection guide600 can be downloaded or transferred from the computer 530 to a machinesuch as a CAD/CAM manufacturing machine, or to a computer coupled tosuch a machine. The resection guide 600 can be made using a rapidprototyping manufacturing devices or process. In rapid prototypingmanufacturing process, a virtual design, such as a computer aided designmodel, is transformed into a physical model or construct. Examples ofrapid prototyping technologies include, but are not limited to,selective laser sintering (SLS), fused deposition modeling (FDM),stereolithography (SLA), and 3D printing, as well as a computernumerical control (CNC) machine. The manufacturing machine 532 makes theresection guide 600 out of any desired material. For example, theresection guide 600 can be partly or entirely made of a suitable polymeror metallic material. Then, the user can perform any desired surgicaloperation on a patient using the resection guide 600. All or some of thesteps shown in FIG. 2A can be executed by a processor or a computer. Inaddition, all or some of the data involved in the method describedabove, such as the virtual models, can be stored on non-transitorycomputer readable storage medium to a local computer or a remotecomputer.

Aside from the resection guide 600, the method described above can beused to make any other suitable resection guide. For example, theresection guides 100 and 200 can be made using the method describedabove. It should be appreciated that all the virtual three-dimensionalmodels mentioned in the present disclosure can be created andmanipulated using a computer aided software that is run in computer 530.The method described in the present application can be used tomanufacture resection guides for use in mandibular reconstructionsurgery as described above. However, the method described in the presentapplication can be used to make resection guides for use in orthognaticsurgery or craniomaxillofacial surgery that may include distraction ofbone segments.

With reference to FIGS. 5A and 5B, the method described above can alsobe used to construct the resection guide 400 used to harvest the graft.In this method, the resection guide 400 can include one or more slots403 and a plurality of drill holes 406 a-406 f. The resection guide 400can be virtually designed so that the location and orientation of thethat the drill holes 406 a-f relative to the graft 320 are insubstantial alignment with the fastener holes 326 a-f and tissuelocations Y when the graft 320 is positioned in the void 14 (FIG. 1C)and the fixation member 322 is positioned against the graft 320 and thetissue body 10. For instance, the virtual three-dimensional model 512 ofthe tissue body 10 is obtained as described above with respect to stepsA-C discussed above and show in FIGS. 2, 3A and 3B. Then, on a virtualthree-dimensional model of the tissue body 10, a first resection region11 (FIG. 1A) and a second resection region 13 (FIG. 1A) are identified.The first resection region 11 is also referred to as the first region11, and the second resection region 13 is also referred to as the secondregion 13. The virtual three-dimensional model 516 of the fixationmember 322 is obtained as described above with respect to FIG. 2. Theobtained three-dimensional model 516 can have a planned post-operativeshape, and can define at least one first hole 326 that is configured toreceive a fastener. The virtual three-dimensional model 516 of thefixation member 322 is processed (in a processor) so as to obtain thevirtual three-dimensional model 516 of the fixation member 322, suchthat a central axis of the at least one first hole 326 a issubstantially aligned with a first target location K of the at thesecond tissue portion 12 a of the tissue body. The virtualthree-dimensional model 401 of the resection guide 400 is created by,for example, scanning the resection guide 400 as described above insteps B and C of FIG. 2. The virtual three-dimensional model 401 of theresection guide 400 can be processed (in a processor) so as to couplethe virtual three-dimensional model 401 of the resection guide 400 tothe virtual three-dimensional model 301 of the graft portion disposedbetween at least two cutting guides 403. The graft portion can be graftportion 304, graft portion 306, graft portion 308, or a combinationthereof. Thus, the graft portion can be the graft 320. The graftportion, such as the graft 320, can be sized to fit in the second region13 or void 14. The virtual three-dimensional model 401 of the resectionguide 400 can be processed via a processor on a computer so as to couplethe virtual three-dimensional model 401 of the resection guide 400 tothe virtual three-dimensional model 301 of the graft portion, such thatthe central axis of one of the drill holes 406 is substantially alignedwith one of the target locations L of the graft source. At least one ofthe target locations L substantially coincides with the target locationK when the graft 320 is positioned in the void 14.

With reference to FIG. 6, a method 700 of making a resection guide caninclude steps 701, 702, 703 and 704. Step 701 includes obtaining avirtual three-dimensional model 516 of a fixation member 322, whereinthe obtained virtual three-dimensional model 516 of the fixation member322 has a planned post-operative shape and defines at least one hole 326that is configured to receive a fastener. Step 702 includes processingthe virtual three-dimensional model of the fixation member 322 so as tocouple the virtual three-dimensional model 516 of the fixation member322 to a first virtual three-dimensional model 520 of the tissue body10, the first virtual three-dimensional model 520 of the tissue body 10defining a first region 11, such that a central axis X of the at leastone hole 326 is substantially aligned with a first target location M ofthe first region 11. The first region 11 can correspond to the tissueportion 12 b. Step 703 includes creating a virtual three-dimensionalmodel 522 of a resection guide 600 that defines at least one cuttingguide 603 and at least one hole 606. Alternatively, step 703 includescreating a virtual three-dimensional model 522 of a guide 600, such as apositioning guide or a drill guide, that defines at least one hole 606.Step 704 includes processing the virtual three-dimensional model 522 ofthe resection guide 600 so as to couple the virtual three-dimensionalmodel 522 of the resection guide 600 to a second virtualthree-dimensional model 521 of the tissue body 10 having a second region13 that is substantially identical to the first region 11, such that acentral axis of the at least one hole 606 is substantially aligned witha second target location N of the second virtual three-dimensional model521 of the tissue body 10, wherein the second target location N ispositioned identically with respect to the first target location Mrelative to the respective first and second virtual three-dimensionalmodels 520, 521 of the tissue body 10.

The second processing step 704 can further include aligning the cuttingguide 603 with a preoperatively planned interface between the firstregion 11 the second region 13 of the tissue body 10. The obtaining step701 can further include scanning the fixation member 322 to obtain animage of the fixation member 322, transferring via communicationnetwork, the image data to a computer and manipulating the image of thefixation member 322 to define the at least one hole 326 of the fixationmember 322 in the virtual three-dimensional model 516 of the fixationmember 322. The manipulating step includes identifying the central axisX of the at least one hole 326. The method can further includeconstructing the resection guide 600 identical to the virtualthree-dimensional model 522 of the resection guide 600 using a rapidprototyping manufacturing process. The step of constructing theresection guide 600 can include transferring the virtualthree-dimensional model 522 of the resection guide 600 from the computerto a manufacturing machine 532.

The obtaining step 701 can include scanning the fixation member 322using a scanning machine 508. The obtaining step 701 can includescanning the fixation member 322 using any one of the following scanningmachines, namely: CT scan machine, laser scanner, optical scanner, MRImachine, or coordinate measure machine. The obtaining step 701 canfurther include coupling the fixation member 322 to a physical model 500of the tissue body 10. The obtaining step 701 can further includebending the fixation member to the post-operative shape. The obtainingstep 701 can further include inserting at least a portion of a marker502 into the at least one hole 326 of the fixation member 322 toidentify a path of the at least one hole 326 relative to a thickness ofthe fixation member 322. The obtaining step 701 can further includescanning the physical model 500 of the tissue body 10, the marker 502that is inserted into at least one hole 326 of the fixation member 322,and the fixation member 322 that is coupled to the physical model 500 ofthe tissue body 10.

The processing step 704 can include manipulating via a processor,according to software stored in a computer readable medium, the virtualthree-dimensional model 522 of the resection guide 600 so that theresection guide 600 is contoured to fit over a particular portion of thevirtual the second virtual three-dimensional model 521 of the tissuebody 10. All or some of the steps shown in FIG. 6 or described above canbe executed by a processor running on a computer. The virtualthree-dimensional models described in the present disclosure can bestored on a non-transitory computer readable storage medium. Theprocessor and the computer readable storage medium can be part of thesame computer or different computers.

With reference to FIG. 6, a method 800 of making a patient specificsurgical resection guide 600 can include the steps 801, 802, and 803.The step 802 includes processing a virtual three-dimensional model 516of a fixation member 322 so as to couple the virtual three-dimensionalmodel 516 of the fixation member 322 to a first virtualthree-dimensional model 520 of the tissue body 10, the first virtualthree-dimensional model 520 of the tissue body 10 defining a firstregion 11, such that a central axis X of the at least one hole 326 issubstantially aligned with a first target location M of the first region11. The step 802 includes creating a virtual three-dimensional model 522of a resection guide 600 that defines at least one cutting guide 603 andat least one hole 606. Alternatively, the step 802 includes creating avirtual three-dimensional model 522 of a guide, such as a positioningguide or a drill guide, that defines at least one hole 606. The step 803includes processing the virtual three-dimensional model 522 of theresection guide 600 so as to couple the virtual three-dimensional model522 of the resection guide 600 to a second virtual three-dimensionalmodel 521 of the tissue body 10 having a second region 13 that issubstantially identical to the first region 11, such that a central axisX of the at least one hole 326 is substantially aligned with a secondtarget location N of the second virtual three-dimensional model 521 ofthe tissue body 10, wherein the second target location N is positionedidentically with respect to the first target location M relative to therespective first and second virtual three-dimensional models 520, 521 ofthe tissue body 10.

In accordance with an alternate embodiment, the method 800 illustratedin FIG. 6 can further include the step obtaining the virtualthree-dimensional model 516 of the fixation member 322 in a computer530. The obtaining step can include scanning the fixation member 322using a scanning machine 508. The obtaining step can further includescanning the fixation member 322 using any of the following scanningmachines, namely CT scan machine, laser scanner, optical scanner, MRImachine, or coordinate measure machine. The method illustrated in FIG. 4can further include constructing the resection guide 600 identical tothe virtual three-dimensional model 522 of the resection guide 600 usinga rapid prototyping manufacturing process. The constructing step canfurther include transferring the virtual three-dimensional model 522 ofthe resection guide 600 from the computer 530 to a manufacturing machine532 via a communications network. The obtaining step can includecoupling the fixation member to a physical model of the tissue body. Theobtaining step can include bending fixation member to the post-operativeshape. The obtaining step can include inserting a marker into the atleast one hole of the fixation member to identify a path of the at leastone hole relative to a thickness of the fixation member. The obtainingstep can include scanning the physical model of the tissue body, themarker that is inserted into at least one hole of the fixation member,and the fixation member that is coupled to the physical model of thetissue body. The obtaining step can include scanning the physical modelof the tissue body, and the fixation member that is coupled to thephysical model of the tissue body. The processing step 803 can includemanipulating the virtual three-dimensional model of the resection guideso that the resection guide is contoured to fit over a particularportion of the virtual the second virtual three-dimensional model of thetissue body. All or some of the steps shown in FIG. 7 or described abovecan be executed by a processor as a computer.

With reference to FIG. 8, a method 900 of making a patient specificsurgical resection guide 600 can include the steps 901, 902, 903, 904,905 and 906. The step 901 includes obtaining a virtual three-dimensionalmodel 521 of the tissue body 10. The step 902 includes identifying onthe virtual three-dimensional model 522 of the tissue body 10 a firstretention region 11 and a second resection region 13. The firstresection region 11 is also referred to as the first region 11, and thesecond resection region 13 is also referred to as the second region 13.The step 903 includes obtaining a virtual three-dimensional model 516 ofa fixation member 322, the obtained virtual three-dimensional model 516of the fixation member 322 having a planned post-operative shape anddefining at least one first hole 326 that is configured to receive afastener. The step 904 includes processing the virtual three-dimensionalmodel 516 of the fixation member 322 so as to couple the virtualthree-dimensional model 516 of the fixation member 322 to the virtualthree-dimensional model of the tissue body 10, such that a central axisX of the at least one first hole 326 is substantially aligned with afirst target location K of the second resection region 13. The step 905includes creating a virtual three-dimensional model 401 of a resectionguide 400 that defines at least a pair of cutting guides 403 and atleast one second hole 406. The step 906 includes processing the virtualthree-dimensional model 401 of the resection guide 400 so as to couplethe virtual three-dimensional model 401 of the resection guide 400 to avirtual three-dimensional model 301 of a graft portion 320 disposedbetween the cutting guides 403, the graft portion 320 sized to fit inthe second region 13, such that a central axis of the at least onesecond hole 406 is substantially aligned with a second target location Lof the three-dimensional model 301 of the graft portion 320, wherein thesecond target location L substantially coincides with respect to thefirst target location K when the graft portion 320 is positioned in thesecond resection region 13. All or some of the steps shown in FIG. 5 ordescribed above can be executed by a processor. The obtaining step 901can further include scanning the fixation member to obtain an image ofthe fixation member, and manipulating the image of the fixation memberto define the at least one first hole of the fixation member in thevirtual three-dimensional model of the fixation member. The manipulatingstep can further include identifying the central axis of the at leastfirst one hole. The method can further comprise the step of constructingthe resection guide identical to the virtual three-dimensional model ofthe resection guide using a rapid prototyping manufacturing process.

It should be noted that the illustrations and discussions of theembodiments shown in the figures are for exemplary purposes only, andshould not be construed limiting the disclosure. One skilled in the artwill appreciate that the present disclosure contemplates variousembodiments. For example, although the present disclosure refers tovirtual three-dimensional models, it is envisioned that any of thevirtual models described in the present disclosure can betwo-dimensional. It should be further appreciated that the features andstructures described and illustrated in accordance one embodiment canapply to all embodiments as described herein, unless otherwiseindicated. Additionally, it should be understood that the conceptsdescribed above with the above-described embodiments may be employedalone or in combination with any of the other embodiments describedabove.

What is claimed:
 1. A method of making a patient specific surgical guidethat is configured to guide a movement of a cutting tool toward a tissuebody, the method comprising: obtaining a virtual three-dimensional modelof a fixation member, the obtained virtual three-dimensional model ofthe fixation member having a planned post-operative shape and definingat least one hole that is configured to receive a fastener; andprocessing the virtual three-dimensional model of the fixation member soas to couple the virtual three-dimensional model of the fixation memberto a first virtual three-dimensional model of the tissue body, the firstvirtual three-dimensional model of the tissue body defining a firstregion, such that a central axis of the at least one hole issubstantially aligned with a first target location of the first region.2. The method according to claim 1, wherein the obtaining step furthercomprises scanning the fixation member to obtain an image of thefixation member, and manipulating the image of the fixation member todefine the at least one hole of the fixation member in the virtualthree-dimensional model of the fixation member.
 3. The method accordingto claim 1, further comprising identifying a central axis of the atleast one hole.
 4. The method according to claim 1, further comprisingconstructing the fixation member identical to the virtualthree-dimensional model of the fixation member using a rapid prototypingmanufacturing process.
 5. The method according to claim 4, wherein theconstructing step includes transferring the virtual three-dimensionalmodel of the fixation member from a computer to a manufacturing machine.6. The method according to claim 1, wherein the step of obtaining thevirtual three-dimensional model of the fixation member includes scanningthe fixation member using a scanning machine.
 7. The method according toclaim 6, wherein the scanning machine is selected from the groupconsisting of CT scan machine, laser scanner, optical scanner, MRImachine, and coordinate measure machine.
 8. The method according toclaim 1, wherein the step of obtaining the virtual three-dimensionalmodel of the fixation member includes coupling the fixation member to aphysical model of the tissue body.
 9. The method according to claim 8,wherein the step of obtaining the virtual three-dimensional model of thefixation member further includes bending the fixation member to thepost-operative shape.
 10. The method according to claim 8, wherein thestep of obtaining the virtual three-dimensional model of the fixationmember further includes inserting a marker into the at least one hole ofthe fixation member to identify a path of the at least one hole relativeto a thickness of the fixation member.
 11. The method according to claim10, wherein the step of obtaining the virtual three-dimensional model ofthe fixation member further includes scanning the physical model of thetissue body, the marker that is inserted into at least one hole of thefixation member, and the fixation member that is coupled to the physicalmodel of the tissue body.